MAUDE Adverse Event Report: ACIST MEDICAL SYSTEMS ACIST; INJECTOR AND SYRINGE, ANGIOGRAPHIC:

Model Number	ACIST
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Air Embolism (1697)
Date of Event	12/20/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Acist multi-use syringe kit, model a2000, lot 19321m; acist single-use manifold kit, model bt2000, lot 21021k; acist angiotouch hand controller kit, model at-x65, lot 13921m.The acist angiographic injection system, model cvi, system serial number (b)(4) was returned on (b)(6) 2022.The injection system was functionally tested and met the pre-established specifications.There was no evidence of device malfunction related to the reported event.The instructions for use have been reviewed and no inadequacies were identified regarding warnings, contraindications, and the directions/conditions for the use of the device.Per the acist cvi user's manual, the air column detect sensor is designed to aid the user in the detection of air columns in the injection line, but it is not designed to replace the vigilance and care required of the operator in visually inspecting for air and clearing air from the entire patient kit and angiographic catheter.The air column detect mechanism is to be used in conjunction with and to complement the user's other procedures for preventing air injections.No consumables or cine-angiograms were returned for evaluation.The device history record review of the reported consumable lot numbers will be completed and a follow-up report will be submitted with this information.
Event or Problem Description
It was reported that during a right and left heart catherization procedure to rule out valvular and coronary artery disease, upon injection of the right coronary artery, air was injected into the patient.The patient experienced st segment elevation and was put on 100% oxygen.The cath lab staff believe they didn't clear the stop cock before catheter exchange.The patient recovered the same day.
Additional Manufacturer Narrative
Review of the cine-angiograms was completed on january 19, 2022.The clinical evaluation by the acist medical advisory board member is as follow: it appears that the air was injected on the first images of the right coronary artery (rca) following catheter exchange.The most likely etiology of this type incident is the operator not fully clearing air from the stopcock, touhy, or catheter.There is no report of significant patient injury.Review of the device history record was completed on january 27 and 28, 2021, for the following cvi consumable kit lots used during the event, the acist manifold kit, model bt2000, lot 21021k; acist hand controller model at-x65, lot 13921m; acist syringe model a2000, lot 19321m.This review confirmed that there were no quality issues during the manufacturing of these lots related to the reported event.This report is closed.

• Brand Name: ACIST
• Common Device Name: INJECTOR AND SYRINGE, ANGIOGRAPHIC:
• Manufacturer (Section D): ACIST MEDICAL SYSTEMS; 7905 fuller road; eden prairie MN 55344
• Manufacturer (Section G): ACIST MEDICAL SYSTEMS; 7905 fuller road; eden prairie MN 55344
• Manufacturer Contact: jeff audritsh ; 7905 fuller road; eden prairie, MN 55344 ; 9529959347
• MDR Report Key: 13286090
• Report Number: 2134243-2022-00002
• Device Sequence Number: 4330684
• Product Code: DXT
• UDI-Device Identifier: 10841716101875
• UDI-Public: (01)10841716101875(11)211110
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K010390
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: ACIST
• Device Catalogue Number: 014657
• Device Lot Number: SEE H10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2021
• Supplement Date Received by Manufacturer: 12/20/2021
• Initial Report FDA Received Date: 01/18/2022
• Supplement Report FDA Received Date: 02/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/20/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BOSTON SCIENTIFIC CAT# 16391-02, 5FR FR4; GE OMNIPAQUE CONTRAST
• Outcome Attributed to Adverse Event: Life Threatening; Hospitalization
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 135 KG